What drug listing information should be included with a repacker's listing?
Answer:
Compared to the source drug, the drug product listing information is usually identical except for the packaging information and the inclusion of the source NDC
Reference(s) :
correspondence between H Shatz and SPL group (FDA)
Subject:
Establishments included in Drug Listing
Question:
What establishments should be included with a repacker's listing?
Answer:
At minimum, the repacking sites should be listed. If known, the manufacturer's name can be included.
Reference(s) :
correspondence between H Shatz and SPL group (FDA)
Subject:
Content of labeling included in Drug Listing
Question:
What parts of the contents of labeling are likely to change when a repacker's listing?
Answer:
The contents of labeling will be the same as the source drug except where revised by the repacker (typically just the how supplied section is revised.
Reference(s) :
correspondence between H Shatz and SPL group (FDA)
Subject:
Re-use of SPL from source drug
Question:
If the SPL of the source drug is used as a basis for the repacker’s SPL, do all the GUIDs in the source drug need to be changed, even if the section text did not change?
Answer:
The setID and document root IDs should definitely be altered in the repackers version of the SPL file. Whether all of the other GUIDS should be altered is still under discussion. However, if in doubt, change them.
Reference(s) :
correspondence between H Shatz and SPL group (FDA)
[24-Nov 2008]
Subject:
Repackager and Establishment Registration Data
Question:
I am a repacker (repackager). If I do not know the DUNS number for an establishment, what do I enter?
Answer:
Include the NDC Product Code -- the first two sections of the NDC -- in the Source NDC Product Code field.
Repack Q&A
[18-Mar-2010]
Subject:
Drug Listing contentQuestion:
What drug listing information should be included with a repacker's listing?Answer:
Compared to the source drug, the drug product listing information is usually identical except for the packaging information and the inclusion of the source NDCReference(s) :
correspondence between H Shatz and SPL group (FDA)Subject:
Establishments included in Drug ListingQuestion:
What establishments should be included with a repacker's listing?Answer:
At minimum, the repacking sites should be listed. If known, the manufacturer's name can be included.
Reference(s) :
correspondence between H Shatz and SPL group (FDA)Subject:
Content of labeling included in Drug ListingQuestion:
What parts of the contents of labeling are likely to change when a repacker's listing?Answer:
The contents of labeling will be the same as the source drug except where revised by the repacker (typically just the how supplied section is revised.
Reference(s) :
correspondence between H Shatz and SPL group (FDA)Subject:
Re-use of SPL from source drugQuestion:
If the SPL of the source drug is used as a basis for the repacker’s SPL, do all the GUIDs in the source drug need to be changed, even if the section text did not change?Answer:
The setID and document root IDs should definitely be altered in the repackers version of the SPL file. Whether all of the other GUIDS should be altered is still under discussion. However, if in doubt, change them.
Reference(s) :
correspondence between H Shatz and SPL group (FDA)[24-Nov 2008]
Subject:
Repackager and Establishment Registration DataQuestion:
I am a repacker (repackager). If I do not know the DUNS number for an establishment, what do I enter?Answer:
Include the NDC Product Code -- the first two sections of the NDC -- in the Source NDC Product Code field.Reference(s) :
DIA Meeting Oct 29-30, 2008